Identificador persistente para citar o vincular este elemento: http://hdl.handle.net/10553/112553
Título: Pembrolizumab Plus Ipilimumab or Placebo for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score ≥ 50%: Randomized, Double-Blind Phase III KEYNOTE-598 Study
Autores/as: Boyer, Michael
Şendur, Mehmet A.N.
Rodríguez Abreu, Delvys 
Park, Keunchil
Lee, Dae Ho
Çiçin, Irfan
Yumuk, Perran Fulden
Orlandi, Francisco J.
Leal, Ticiana A.
Molinier, Olivier
Soparattanapaisarn, Nopadol
Langleben, Adrian
Califano, Raffaele
Medgyasszay, Balazs
Hsia, Te Chun
Otterson, Gregory A.
Xu, Lu
Piperdi, Bilal
Samkari, Ayman
Reck, Martin
Clasificación UNESCO: 32 Ciencias médicas
320713 Oncología
Palabras clave: Pembrolizumab
Ipilimumab
Placebo
Lung cancer
PD-L1, et al.
Fecha de publicación: 2021
Publicación seriada: Journal of Clinical Oncology 
Resumen: PURPOSE: Pembrolizumab monotherapy is standard first-line therapy for metastatic non-small-cell lung cancer (NSCLC) with programmed death ligand 1 (PD-L1) tumor proportion score (TPS) ≥ 50% without actionable driver mutations. It is not known whether adding ipilimumab to pembrolizumab improves efficacy over pembrolizumab alone in this population. METHODS: In the randomized, double-blind, phase III KEYNOTE-598 trial (ClinicalTrials.gov identifier: NCT03302234), eligible patients with previously untreated metastatic NSCLC with PD-L1 TPS ≥ 50% and no sensitizing EGFR or ALK aberrations were randomly allocated 1:1 to ipilimumab 1 mg/kg or placebo every 6 weeks for up to 18 doses; all participants received pembrolizumab 200 mg every 3 weeks for up to 35 doses. Primary end points were overall survival and progression-free survival. RESULTS: Of the 568 participants, 284 were randomly allocated to each group. Median overall survival was 21.4 months for pembrolizumab-ipilimumab versus 21.9 months for pembrolizumab-placebo (hazard ratio, 1.08; 95% CI, 0.85 to 1.37; P = .74). Median progression-free survival was 8.2 months for pembrolizumab-ipilimumab versus 8.4 months for pembrolizumab-placebo (hazard ratio, 1.06; 95% CI, 0.86 to 1.30; P = .72). Grade 3-5 adverse events occurred in 62.4% of pembrolizumab-ipilimumab recipients versus 50.2% of pembrolizumab-placebo recipients and led to death in 13.1% versus 7.5%. The external data and safety monitoring committee recommended that the study be stopped for futility and that participants discontinue ipilimumab and placebo. CONCLUSION: Adding ipilimumab to pembrolizumab does not improve efficacy and is associated with greater toxicity than pembrolizumab monotherapy as first-line treatment for metastatic NSCLC with PD-L1 TPS ≥ 50% and no targetable EGFR or ALK aberrations. These data do not support use of pembrolizumab-ipilimumab in place of pembrolizumab monotherapy in this population.
URI: http://hdl.handle.net/10553/112553
ISSN: 0732-183X
DOI: 10.1200/JCO.20.03579
Fuente: Journal of Clinical Oncology [ISSN 0732-183X], v. 39(21), p. 2327-2338 (Enero 2021)
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